Case Detail

Goldwater Institute v. United States Department of Health and Human Services

District

District of Arizona

City

Phoenix Division

Case Number

2:2015cv01055

Date Filed

2015-06-09

Date Closed

2019-02-08

Judge

Senior Judge Susan R Bolton

Plaintiff

Goldwater Institute

Case Description

The Goldwater Institute submitted a FOIA request to the Food and Drug Administration for records concerning whether ZMapp, an experimental drug given to two U.S. citizens who contracted Ebola, had been approved under the compassion use process for investigational new drugs. The Goldwater Institute also requested a fee waiver. The agency granted the fee waiver, but was denied access to the records under Exemption 4 (confidential business information). The Goldwater Institute appealed the decision, which was upheld. The Goldwater Institute then filed suit.Complaint issues: Litigation - Attorney's fees, Exemption 4 - Confidential business information

FOIA Project Annotation: A federal court in Arizona has ruled that the FDA has not yet justified its claims that records about ZMapp, currently being considered for approval under an Investigational New Drug application, are protected by Exemption 4 (confidential business information) or Exemption 6 (invasion of privacy), but that because the Goldwater Institute requested records about deliberations during the approval process such records are protected by Exemption 5 (deliberative process privilege). Based on press reports that Dr. Kent Brantly and Nancy Writebol, two health workers who contracted the Ebola virus while working in Africa, had been flown to the United States and treated successfully with ZMapp, the Goldwater Institute requested the agency's records on ZMapp, arguing that the existence of the IND application had been publicly acknowledged. After learning that Brantly and Writebol had disclosed in a report that they received three doses of ZMapp, the FDA disclosed two emails authorizing Brantley and Writebol's expanded access to ZMapp to proceed. The agency, however, insisted that the rest of the documents were protected by Exemption 4, Exemption 5, and Exemption 6. Faulting the agency for not providing an index of the records it claimed were exempt, the court noted that "it is unclear to the Court, which if any, responsive documents would fall under [Exemption 4]. Defendant has not provided a catalog of the documents in their supporting memorandum." The court added that it "cannot conclude that Defendant's assertion that trade secrets and [confidential commercial information] are 'inextricably intertwined' alone is sufficient to meet its burden. Therefore, the Court reserves judgment on whether Defendant lawfully denied Plaintiff's request based on FOIA Exemption 4." The court was considerably more certain as to Exemption 5. "Plaintiff's FOIA Request expressly asked for documents reflecting the FDA's 'deliberations made during [the authorization] process.' By the very nature of the documents sought, the Court concludes that Defendant lawfully withheld at least some documents under Exemption 5." The court found the agency had not sufficiently explained its claims under Exemption 6. The court noted that "it is unclear to the Court what personal information Plaintiff seeks that would fall under this Exemption. Like Exemption 4, the Court is left without a description or index of the documents to determine if Defendant has met its burden particularly when Dr. Brantly and Ms. Writebol both disclosed their participation in ZMapp INDs." The court observed that "defendant identified nine volumes of responsive records in its initial denial. Because the Court is unable to determine if the exemptions apply based on the generalizations given in [the agency's affidavit], the Court orders Defendant to submit a Vaughn index within 60 days of the date of this Order."
Issues: Exemption 4 - Confidential business information, Exemption 6 - Invasion of privacy, Litigation - Vaughn index

Filing fee paid, receipt number 0970-11769236. This case has been assigned to the Honorable Susan R. Bolton. All future pleadings or documents should bear the correct case number: CV-15-1055-PHX-SRB. Notice of Availability of Magistrate Judge to Exercise Jurisdiction form attached. (ATD) (Entered: 06/09/2015)

Summons Issued as to United States Department of Health and Human Services. (BAS). *** IMPORTANT: When printing the summons, select "Document and stamps" or "Document and comments" for the seal to appear on the document. (Entered: 06/10/2015)

2015-06-10

6

ORDER that motions pursuant to Fed. R. Civ. P. 12(b) are discouraged if the defect can be cured by filing an amended pleading. The parties must meet and confer prior to the filing of such motions to determine whether it can be avoided. FURTHER ORDERED that Plaintiff(s) serve a copy of this Order upon Defendant(s) and file a notice of service. See attached Order for complete details. Signed by Judge Susan R Bolton on 6/10/15. (MAW) (Entered: 06/10/2015)

2015-06-15

7

SERVICE EXECUTED filed by Goldwater Institute: Affidavit of Service re: Summons, Complaint, Corporate Disclosure Statement, Order upon U.S. Attorney's Office, District of Arizona on 06/10/2015. (Riches, Jonathan) (Entered: 06/15/2015)

2015-06-17

8

SCHEDULING ORDER: IT IS ORDERED that defendant shall serve an answer or otherwise plead within thirty (30) days after service [see attached Order for details]. Signed by Judge Susan R Bolton on 6/17/15. (MAW) (Entered: 06/17/2015)

ORDER: Application is GRANTED. IT IS FURTHER ORDERED that attorney Courtney Van Cott will henceforth not be an attorney of record in this case and attorney Aditya Dynar will henceforth be an attorney of record in this case. Signed by Judge Susan R Bolton on 09/14/2015. (REK) (Entered: 09/15/2015)

2015-10-02

16

MOTION to Stay Defendant's Response to Plaintiff's Requests for Admissions (Stipulated) by United States Department of Health and Human Services. (Attachments: # 1 Text of Proposed Order)(Johns, Michael) (Entered: 10/02/2015)

2015-10-05

17

ORDER granting 16 staying the due date to respond to Plaintiffs Request forAdmissions until after Defendant files its Motion for Summary Judgment in this action. Signed by Judge Susan R Bolton on 10/5/2015.(TCA) (Entered: 10/05/2015)

2015-10-08

18

STIPULATION TO REVISE SEQUENCE AND TIMING OF DISPOSITIVE MOTIONS by United States Department of Health and Human Services. (Attachments: # 1 Text of Proposed Order)(Johns, Michael) (Entered: 10/08/2015)

2015-10-08

19

ORDER granting 18 Stipulation : Defendant shall file its dispositive motion on or before November 24, 2015 and Plaintiff shall file its Response and any Cross-Motion on or before January 8, 2016. Signed by Judge Susan R Bolton on 10/8/2015. (TCA) (Entered: 10/08/2015)

2015-11-24

20

MOTION for Summary Judgment by United States Department of Health and Human Services. (Johns, Michael) (Entered: 11/24/2015)

MEMORANDUM in Support of Response to Motion for Summary Judgment and Cross Motion for Summary Judgment 24 Response to Motion for Summary Judgment by Plaintiff Goldwater Institute. (Riches, Jonathan) (Entered: 01/08/2016)

ORDER: The Court having considered Plaintiff's Application for Withdrawal of Clint Bolick as Counsel of Record, and good cause appearing, IT IS ORDERED that the Application is GRANTED. IT IS FURTHER ORDERED that attorney Clint Bolick will henceforth not be an attorney of record in this case. IT IS FURTHER ORDERED directing the Clerk of the Court to make appropriate changes in the Court's CM/ECF System to reflect this change. Signed by Judge Susan R Bolton on 1/14/2016. (REK) (Entered: 01/14/2016)

2016-01-22

30

* MOTION for Extension of Time to File Response/Reply Unopposed Page Consolidated In Support of Motion for Summary Judgment re: 20 MOTION for Summary Judgment by United States Department of Health and Human Services. (Attachments: # 1 Text of Proposed Order)(Lantka, Peter) *Modified to add link on 1/25/2016 (REK). (Entered: 01/22/2016)

2016-01-26

31

ORDER: IT IS ORDERED granting in part and denying in part Defendant's Unopposed Motion to File 25-Page Consolidated Response/Reply in Support of Motion for Summary Judgment 30 . Defendant's Response/Reply may not exceed 11 pages but Defendant may have until February 23, 2016 to file its Response/Reply [see attached Order for details]. Signed by Judge Susan R Bolton on 1/26/16.(MAW) (Entered: 01/26/2016)

2016-02-11

32

Second MOTION for Extension of Time to File Response/Reply In Support of Motion for Summary Judgment By or Before March 15, 2016 by United States Department of Health and Human Services. (Attachments: # 1 Text of Proposed Order)(Lantka, Peter) (Entered: 02/11/2016)

2016-02-12

33

ORDER granting 32 Motion for Extension of Time to File Response/Reply. The United States' deadline to file a Consolidated Response/Reply in support if its Motion for Summary Judgment is extended to March 15, 2016. Signed by Judge Susan R Bolton on 2/12/16.(MAW) (Entered: 02/12/2016)

2016-03-15

34

* REPLY IN SUPPORT OF DEFENDANT'S 20 MOTION FOR SUMMARY JUDGMENT AND IN OPPOSITION TO PLAINTIFF'S CROSS MOTION FOR SUMMARY JUDGMENT by Defendant United States Department of Health and Human Services. (Lantka, Peter) * Modified to correct document linkage on 3/16/2016 (LAD). (Entered: 03/15/2016)

ORDER: IT IS ORDERED denying both Motions for Summary Judgment without prejudice to be resubmitted after the Vaughn index is filed (Docs. 21 & 24 ). IT IS FURTHER ORDERED directing Defendant to file a Vaughn index within sixty (60) days of the date of this Order [see attached Order for details]. Signed by Judge Susan R Bolton on 6/16/16.(MAW) (Entered: 06/16/2016)

2016-08-12

37

First MOTION for Extension of Time To File Vaughn Index By Seven Days (Unopposed) by United States Department of Health and Human Services. (Attachments: # 1 Text of Proposed Order)(Lantka, Peter) (Entered: 08/12/2016)

2016-08-17

38

ORDER granting 37 Motion for Extension of Time. The United States' deadline to file a Vaughn Index is extended to August 22, 2016. Signed by Judge Susan R Bolton on 8/17/16.(MAW) (Entered: 08/17/2016)

2016-08-19

39

*Defendant's Submission of Third DECLARATION of Nancy B Sager with Vaughn Index, MOTION For Leave To File Under Seal The Fourth Declaration Of Nancy B. Sager For In Camera Review by United States Department of Health and Human Services . (Attachments: # 1 Exhibit A, # 2 Text of Proposed Order)(Lantka, Peter) *Modified to correct event and docket text on 8/22/2016 (REK). (Entered: 08/19/2016)

*REPLY to Response to Motion re: 39 MOTION to Seal Document In Support of Motion for Leave to File Under Seal The Fourth Declaration of Nancy B. Sager for In Camera Review by Defendant United States Department of Health and Human Services. (Lantka, Peter) *Modified to correct event on 9/9/2016 (REK). (Entered: 09/08/2016)

2016-10-12

42

NOTICE of Appearance by Ann Elizabeth Harwood on behalf of United States Department of Health and Human Services. (Harwood, Ann) (Entered: 10/12/2016)

2016-10-21

43

ORDER: IT IS ORDERED denying 39 Defendant's Motion for Leave to File Under Seal the Fourth Declaration of Nancy B. Sager for In Camera Review [see attached Order for details]. Signed by Judge Susan R Bolton on 10/21/16.(MAW) (Entered: 10/21/2016)

STIPULATION Motion for Renewed Scheduling Order by United States Department of Health and Human Services. (Attachments: # 1 Text of Proposed Order)(Lantka, Peter) (Entered: 03/20/2017)

2017-03-21

47

ORDER granting 46 Stipulation for Renewed Scheduling Order. Plaintiff's Opening Brief to be filed by 6/2/2017 [see attached Order for details]. Signed by Judge Susan R Bolton on 3/21/17. (MAW) (Entered: 03/21/2017)

2017-05-25

48

First MOTION for Extension of Time Modify Briefing Schedule (Unopposed) by United States Department of Health and Human Services. (Attachments: # 1 Text of Proposed Order)(Lantka, Peter) (Entered: 05/25/2017)

2017-05-26

49

ORDER granting 48 Motion to Modify Briefing Schedule. The following deadlines shall govern the final briefing schedule for filing amended cross-motions for summary judgment, pursuant to this Court's June 16, 2016 Order: Plaintiff's Opening Brief June 19, 2017; Defendant's Response Brief / Cross-Motion August 3, 2017; Plaintiff's Reply in Support of Motion / Response to Cross-Motion August 24, 2017; Defendant's Reply in Support of Cross-Motion September 14, 2017. Signed by Judge Susan R Bolton on 5/26/17.(MAW) (Entered: 05/26/2017)

MINUTE ORDER: Motion Hearing set for 10/2/2017 at 01:30PM before Judge Susan R Bolton as to 50 MOTION for Summary Judgment. This is a TEXT ENTRY ONLY. There is no PDF document associated with this entry. (MAW) (Entered: 06/26/2017)

2017-08-03

53

*MOTION for Summary Judgment (Renewed), RESPONSE to 50 Motion for Summary Judgment by United States Department of Health and Human Services. (Lantka, Peter) *Modified to add response portion on 8/4/2017 (REK). (Entered: 08/03/2017)

*STATEMENT OF FACTS of Additional Material Not Genuinely in Dispute and Response to Plaintiff's Separate Statement of Facts, Submitted in Opposition to Plaintiff's Motion for Summary Judgment re: 51 State of Facts and 53 Response to Motion for Summary Judgment by Defendant United States Department of Health and Human Services. (Lantka, Peter) *Modified to add document link on 8/4/2017 (REK). (Entered: 08/03/2017)

2017-08-11

56

MINUTE ORDER: On the Court's own Motion, Motion Hearing is re-set from 10/2/2017 to 10/3/2017 at 11:15AM before Judge Susan R Bolton as to 50 MOTION for Summary Judgment. This is a TEXT ENTRY ONLY. There is no PDF document associated with this entry. (MAW) (Entered: 08/11/2017)

ORDER granting 60 Stipulated Motion to Continue Oral Argument. Oral argument in this matter is rescheduled to Tuesday, October 10, 2017 at 9:00 a.m. Signed by Judge Susan R Bolton on 8/31/17. (MAW) (Entered: 08/31/2017)

2017-09-13

62

*REPLY to Response to Motion re: 53 MOTION for Summary Judgment Renewed and In Opposition to Plaintiff's Motion for Summary Judgment filed by United States Department of Health and Human Services. (Lantka, Peter) *Modified to correct event on 9/14/2017 (REK). (Entered: 09/13/2017)

ORDER: IT IS ORDERED denying both Motions for Summary Judgment without prejudice (Docs. 50 & 53 ). IT IS FURTHER ORDERED directing Defendant to file a revised, consolidated Vaughn index containing the additional information called for in this Order within thirty (30) days of the date of this Order [see attached Order for details]. Signed by Senior Judge Susan R Bolton on 1/24/18. (MAW) (Entered: 01/24/2018)

2018-02-15

67

First MOTION for Extension of Time Unopposed Motion to Extend Dealine to File Vaughn Index by United States Department of Health and Human Services. (Attachments: # 1 Text of Proposed Order)(Lantka, Peter) (Entered: 02/15/2018)

2018-02-16

68

ORDER granting 67 Motion to Extend Time to file a consolidated Vaughn index and that the deadline for Defendant to file its consolidated Vaughn index is extended through March 9, 2018. Signed by Senior Judge Susan R Bolton on 2/16/18. (MAW) (Entered: 02/16/2018)

NOTICE TO FILER OF DEFICIENCY re: 73 Third MOTION for Summary Judgment filed by Goldwater Institute, 75 Statement of Facts filed by Goldwater Institute, 74 Memorandum filed by Goldwater Institute. Document not in compliance with LRCiv 7.1(a)(3) - Party names must be capitalized using proper upper and lower case type. No further action is required. This is a TEXT ENTRY ONLY. There is no PDF document associated with this entry. (REK) (Entered: 07/02/2018)

2018-08-29

77

*MOTION for Summary Judgment (Renewed) and RESPONSE in Opposition re: 73 Third MOTION for Summary Judgment by United States Department of Health and Human Services. (Lantka, Peter) *Modified on 8/30/2018 to correct motion event and to add Response (ATD). (Entered: 08/29/2018)

2018-08-29

78

STATEMENT OF FACTS re: 77 MOTION for Summary Judgment (Renewed) and Response in Opposition re: 73 Third MOTION for Summary Judgment by Defendant United States Department of Health and Human Services. (Lantka, Peter) (Entered: 08/29/2018)

2018-09-11

79

RESPONSE re: 78 Statement of Facts Not Genuinely in Dispute in Support of Renewed Motion for Summary Judgment by Plaintiff Goldwater Institute. (Dynar, Aditya) (Entered: 09/11/2018)

2018-10-16

80

MINUTE ORDER: Motion Hearing set for 10/29/2018 at 10:00 AM before Senior Judge Susan R Bolton as to 73 Third MOTION for Summary Judgment. This is a TEXT ENTRY ONLY. There is no PDF document associated with this entry. (MAW) (Entered: 10/16/2018)

ORDER granting 81 Motion to Continue Oral Argument and oral argument on the parties' third cross-motions for summary judgment is continued to December 4, 2018, at 10:00 a.m. Signed by Senior Judge Susan R Bolton on 10/19/18. (MAW) (Entered: 10/19/2018)

2018-12-04

84

MINUTE ENTRY for proceedings held before Senior Judge Susan R Bolton: Motion Hearing held on 12/4/2018. Argument held. IT IS ORDERED taking under advisement 73 Motion for Summary Judgment. APPEARANCES: Jonathan Riches and Aditya Dynar for Plaintiff. Peter Lantka for Defendant. (Court Reporter Laurie Adams) Hearing held 10:01 AM to 10:50 AM. This is a TEXT ENTRY ONLY. There is no PDF document associated with this entry. (MAW) (Entered: 12/04/2018)

2019-02-08

85

ORDER denying Plaintiff's Third Motion for Summary Judgment (Doc. 73 ) and granting Defendant's Renewed Motion for Summary Judgment (Doc. 77 ). FURTHER ORDERED directing the Clerk to enter judgment in favor of Defendant and against Plaintiff. See document for further details. Signed by Senior Judge Susan R Bolton on 2/8/2019. (RMV) (Entered: 02/08/2019)

2019-02-08

86

CLERK'S JUDGMENT - IT IS ORDERED AND ADJUDGED that, pursuant to the Court's Order filed February 8, 2019, which granted the Motion for Summary Judgment, judgment is entered in favor of defendant and against plaintiff. Plaintiff to take nothing, and the complaint and action are dismissed. (RMV) (Entered: 02/08/2019)